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Model Number RBY4C0860-B |
Device Problems
Material Deformation (2976); Premature Separation (4045)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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Event Description
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The patient was undergoing a coil embolization procedure in the hypogastric artery using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, after advancing approximately 35 centimeters of the ruby coil through the lantern, the ruby coil had unintentionally detached.It was reported that the physician flushed the lantern prior to advancing the ruby coil.Therefore, the lantern containing the detached ruby coil was removed and the coil was flushed out.It was also reported that the hospital technologist noticed the pusher assembly of the ruby coil to be kinked upon initially removing the coil from the packaging hoop.The procedure was completed using a new ruby coil and the same lantern.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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